Biopharmaceutical company AbbVie (ABBV) said Tuesday that Health Canada has approved VENCLEXTA (venetoclax) in combination with azacitidine or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
AML is an aggressive and difficult-to-treat blood cancer with a low survival rate. In Canada, the five-year survival rate for patients diagnosed with AML is about 21 percent.
Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
AbbVie noted that in the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months compared to 9.6 months in patients who received azacitidine in combination with placebo. In the VIALE-C trial, clinical benefit was based on rate and duration of complete response (CR).
In the VENCLEXTA plus azacitidine arm, the most frequent serious adverse reactions were febrile neutropenia, pneumonia, sepsis and hemorrhage.
Health Canada's approval was granted under Project Orbis, an FDA initiative which provides a framework for concurrent submission and review of oncology products among international partners.
For comments and feedback contact: editorial@rttnews.com
